Dataset Information

Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus.

ABSTRACT: BACKGROUND:Type 2 diabetes (T2DM) patients, including those in good glycemic control, have an increased risk of cardiovascular disease (CVD). Maintaining good glycemic control may reduce long-term CVD risk. However, other risk factors such as elevated vascular sympathetic tone and/or endothelial dysfunction may be stronger potentiators of CVD. This study evaluated the impact of bromocriptine-QR, a sympatholytic dopamine D2 receptor agonist, on progression of metabolic disease and CVD in T2DM subjects in good glycemic control (HbA1c ? 7.0%). METHODS:1834 subjects (1219 bromocriptine-QR; 615 placebo) with baseline HbA1c ? 7.0% derived from the Cycloset Safety Trial (this trial is registered with ClinicalTrials.gov Identifier: NCT00377676), a 12-month, randomized, multicenter, placebo-controlled, double-blind study in T2DM, were evaluated. Treatment impact upon a prespecified composite CVD endpoint (first myocardial infarction, stroke, coronary revascularization, or hospitalization for angina/congestive heart failure) and the odds of losing glycemic control (HbA1c >7.0% after 52 weeks of therapy) were determined. RESULTS:Bromocriptine-QR reduced the CVD endpoint by 48% (intention-to-treat; HR: 0.52 [0.28-0.98]) and 52% (on-treatment analysis; HR: 0.48 [0.24-0.95]). Bromocriptine-QR also reduced the odds of both losing glycemic control (OR: 0.63 (0.47-0.85), p = 0.002) and requiring treatment intensification to maintain HbA1c ? 7.0% (OR: 0.46 (0.31-0.69), p = 0.0002). CONCLUSIONS:Bromocriptine-QR therapy slowed the progression of CVD and metabolic disease in T2DM subjects in good glycemic control.

SUBMITTER: Chamarthi B

PROVIDER: S-EPMC4427775 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus.

Chamarthi Bindu B Gaziano J Michael JM Blonde Lawrence L Vinik Aaron A Scranton Richard E RE Ezrokhi Michael M Rutty Dean D Cincotta Anthony H AH

Journal of diabetes research 20150428

<h4>Background</h4>Type 2 diabetes (T2DM) patients, including those in good glycemic control, have an increased risk of cardiovascular disease (CVD). Maintaining good glycemic control may reduce long-term CVD risk. However, other risk factors such as elevated vascular sympathetic tone and/or endothelial dysfunction may be stronger potentiators of CVD. This study evaluated the impact of bromocriptine-QR, a sympatholytic dopamine D2 receptor agonist, on progression of metabolic disease and CVD in ...[more]

PMID: 26060823

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Project description:Objective:Sympathetic nervous system (SNS) overactivity is a risk factor for insulin resistance and cardiovascular disease (CVD). We evaluated the impact of bromocriptine-QR, a dopamine-agonist antidiabetes medication, on elevated resting heart rate (RHR) (a marker of SNS overactivity in metabolic syndrome), blood pressure (BP) and the relationship between bromocriptine-QR's effects on RHR and HbA1c in type 2 diabetes subjects. Design and Subjects:RHR and BP changes were evaluated in this post hoc analysis of data from a randomized controlled trial in 1014 type 2 diabetes subjects randomized to bromocriptine-QR vs placebo added to standard therapy (diet ± ?2 oral antidiabetes medications) for 24 weeks without concomitant antihypertensive or antidiabetes medication changes, stratified by baseline RHR (bRHR). Results:In subjects with bRHR ?70 beats/min, bromocriptine-QR vs placebo reduced RHR by -3.4 beats/min and reduced BP (baseline 130/79; systolic, diastolic, mean arterial BP reductions [mm Hg]: -3.6 [P = .02], -1.9 [P = .05], -2.5 [P = .02]). RHR reductions increased with higher baseline HbA1c (bHbA1c) (-2.7 [P = .03], -5 [P = .002], -6.1 [P = .002] with bHbA1c ?7, >7, ?7.5%, respectively] in the bRHR ?70 group and more so with bRHR ?80 (-4.5 [P = .07], -7.8 [P = .015], -9.9 [P = .005]). Subjects with bRHR <70 had no significant change in RHR or BP. With bHbA1c ?7.5%, %HbA1c reductions with bromocriptine-QR vs placebo were -0.50 (P = .04), -0.73 (P = .005) and -1.22 (P = .008) with bRHR <70, ?70 and ?80, respectively. With bRHR ?70, the magnitude of bromocriptine-QR-induced RHR reduction was an independent predictor of bromocriptine-QR's HbA1c lowering effect. Conclusion:Bromocriptine-QR lowers elevated RHR with concurrent decrease in BP and hyperglycaemia. These findings suggest a potential sympatholytic mechanism contributing to bromocriptine-QR's antidiabetes effect and potentially its previously demonstrated effect to reduce CVD events.

Dataset Information

Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus.

Publications

Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes Mellitus.

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